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T-Cell Therapy (ECT204) in Adults With Advanced HCC
Trial Status: active
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at
assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204
T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed
with GPC3-positive HCC, who have failed or not tolerated at least two (2) different
anti-HCC systemic agents.
The study includes a dose escalation phase (Part 1 or Phase I) to determine the
Recommended Phase II Dose (RP2D), followed by an expansion phase (Part 2 or Phase II) to
further assess safety and efficacy.
Inclusion Criteria
Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
GPC3-positive expression in HCC tumor cells confirmed by immunohistochemistry (IHC).
For Phase 1 (dose escalation): ≥10-20% tumor cells, ≥2+ IHC).
For Phase 2 (expansion): ≥ 50% tumor cells, 2+/3+ IHC).
Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
Life expectancy of at least 4 months per the Investigator's opinion.
Karnofsky Performance Scale of 70 or higher.
Measurable disease by RECIST v1.1. Previously treated lesions are allowed as long as there is a new confirmed measurable component.
Child-Pugh score of A6 or better.
Adequate organ function.
Exclusion Criteria
Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy).
Currently receiving or ending (< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
Active autoimmune disease requiring therapy.
Compromised circulation in the main portal vein, hepatic vein, or vena cava due to obstruction.
History of organ transplant.
Advanced HCC involving greater than half (50%) of the liver.
Additional locations may be listed on ClinicalTrials.gov for NCT04864054.
